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Comparison of Two Treatments in Intermediate and High-risk Acute Promyelocytic Leukemia (APL) Patients to Assess Efficacy in 1st Hematological Complete Remission and Molecular Remission

Last updated on May 10, 2018

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Study Location
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1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Myelocytic Leukemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-61 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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1. Patients with untreated newly diagnosed and genetically proven APL (leukemic cells at
diagnosis with the t(15;17) and/or the PML/RARα rearrangement by RT-PCR; the presence
of additional cytogenetic lesions is not considered an exclusion criterion) with
intermediate and high risk disease.

2. Male and female patients age > 18 years and

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

1. Low risk patients (WBC 40 x 109/L).

2. Absence of PML-RAR ? rearrangement in leukemic cells after successful RNA extraction
and amplification of control gene.

3. Pretreated APL.

NCT00962767
Pfizer
Completed
Comparison of Two Treatments in Intermediate and High-risk Acute Promyelocytic Leukemia (APL) Patients to Assess Efficacy in 1st Hematological Complete Remission and Molecular Remission

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Comparison of Two Treatments in Intermediate and High-risk Acute Promyelocytic Leukemia (APL) Patients to Assess Efficacy in 1st Hematological Complete Remission and Molecular Remission
A Randomized Study of Two Doses Gemtuzumab Ozogamicin vs. A Two-year Maintenance With Atra Plus Chemotherapy as Post-consolidation Treatment for Intermediate and High-risk Adult Patients With Acute Promyelocytic Leukemia (Apl)
The study will compare the efficacy of the 2 treatments in intermediate and high-risk APL patients in achieving first hematological complete remission and molecular remission.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Leukemia, Myelocytic, Acute
  • Drug: gemtuzumab ozogamicin
    2 IV infusions 6 mg/m2 administered monthly
    Other Name: Arm A
  • Drug: ATRA plus 6-MP and MTX
    6-MP 50 mg/m2/day PO; MTX 15 mg/m2/q week IM; ATRA 45 mg/m2/day PO
    Other Name: Arm B
  • Experimental: a
    2 doses of gemtuzumab ozogamicn administered at monthly intervals
    Intervention: Drug: gemtuzumab ozogamicin
  • Active Comparator: b
    2 years maintenance therapy with intermittent ATRA plus 6-Mercaptopurine (6-MP) and methotrexate (MTX)
    Intervention: Drug: ATRA plus 6-MP and MTX
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
168
December 2007
December 2007   (Final data collection date for primary outcome measure)

Inclusion criteria:

  1. Patients with untreated newly diagnosed and genetically proven APL (leukemic cells at diagnosis with the t(15;17) and/or the PML/RAR? rearrangement by RT-PCR; the presence of additional cytogenetic lesions is not considered an exclusion criterion) with intermediate and high risk disease.
  2. Male and female patients age > 18 years and < 61 years.

Exclusion criteria:

  1. Low risk patients (WBC < 10 x 109/L and platelets > 40 x 109/L).
  2. Absence of PML-RAR ? rearrangement in leukemic cells after successful RNA extraction and amplification of control gene.
  3. Pretreated APL.
Sexes Eligible for Study: All
18 Years to 61 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00962767
0903X-101128
Yes
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
August 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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